| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00853-1 |
| Product Name/Description |
Medtronic CryoConsole
(A unit that applies a gaseous or liquid refrigerant to withdraw heat from target tissues or indirectly through contact with a cryogen-cooled probe.)
Models 106A3, 106E2, 106A2-K
ARTG Number: 164650 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified a performance issue with a USB memory component that contains some of the system's software within a subset of CryoConsole models.
Testing indicated that the write speed of the USB memory component from a single supplier lot is slower than those compared to other lots. Based on data from field complaints and internal testing, the difference in speed is known to cause the following issues:-
1. During inflation of a cryoballon catheter, false detection of balloon deflation and display of system notice 22406 (The balloon is deflated);
2. During a procedure, display of system notice 50008 (The system has detected a software error and stopped the injection).
No injuries have been reported. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised that if a system notice appears, to carefully read and follow the instructions on the screen of the console. A Medtronic representative will also contact users to arrange a service of their CryoConsole system. This action has been closed-out on 18/08/2016. |
| Contact Information |
1800 668 670 - Medtronic |